quality management for high technology hank canitz – sr. director industry solutions, qad bob...

Quality Management for High Technology

Hank Canitz – Sr. Director Industry Solutions, QADBob Herdoiza – President of Cebos

QAD Midwest User Group

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The following is intended to outline QAD’s general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, functional capabilities, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functional capabilities described for QAD’s products remains at the sole discretion of QAD.

Safe Harbor Statement


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• Problem Statement• Relevant global safety & environmental

regulations and how to comply• QAD core solutions that meet the

requirements of these regulations• How Cebos QMS can help with compliance

Agenda


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• Regulation has risen dramatically over the past 20 years (over 2100 unique regulations)

• In the US the average number of new major regulations has risen with each administration- Bill Clinton: 27 per year- George W. Bush: 35 per year- Barack Hussein Obama: 44 per year

• The cost of regulation has been growing much faster than the output of manufacturing

• Regulatory burden on manufacturers has more than tripled in the last 10 years

Problem Statement


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Cost of Regulations on Manufacturing


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• Good Manufacturing Principles (GMP)• International Standards Organization (ISO)• Waste Electrical and Electronic Equipment

(WEEE)• Restrictions on Hazardous Substances

(RoHS)• Wall Street Reform and Consumer

Protection Act (Conflict Minerals)

Important Regulations for High Tech


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•Term for Good Practice quality guidelines and regulations

GxP

•current Good Manufacturing Practices

cGMP

•current Good Distribution Practices

cGDP

•current Good Transportation Practices

cGTP

What do we mean by “GxP?”


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• ISO 9000 Family- Addresses various aspects of quality management

- Guidance & tools to ensure products / services consistently meet customer’s requirements, & are consistently improved

- ISO 9001:2008 can be certified to

• ISO14001 Family- Addresses various aspects of environmental mgt

- Tools to identify and control environmental impact and constantly improve environmental performance

- ISO 14001:2004 can be certified to

Relevant ISO Standards


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• What is it?- Encourages the collection, treatment, recycling and

recovery of electrical waste & electronic equipment - Makes producers & importers responsible for

financing of the collection, treatment & recovery of WEEE

- More information available by reviewing Directive 2002/96/EC, as amended by 2003/108/EC

• Who does it apply to? Just about all Electronic Mfgs.

• Complying- Register with a compliance scheme- End of product life plan- Mark the products

Waste Electrical & Electronic Equipment (WEEE)


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• What is it?- Bans new electronic equipment in EU market- Works in conjunction with WEEE- Effective July 1, 2006- More information available at www.rohs.gov.uk

• Who does it apply to?- Any mfg who distributes or sells their products in the EU.

• How do you comply?- Documentation to show that products are compliant

before placing them on the market- If requested, documentation must be provided to the

RoHS Enforcement Authority within 28 days- Documentation must continue to be maintained for 4 yrs

after product is sold on the market

Restriction of Hazardous Substances (RoHS)


http://www.rohs.gov.uk/

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• What is it? - New law imposing requirements relating certain

minerals that are sourced from mines• Under the control of violent forces • Democratic Republic of Congo (DRC)

- Aims to cut funding to armed groups that commit violent human rights violations

• Who does it apply to?• All publicly traded mfg companies • Must report annually to the SEC on use of conflict minerals• Private companies are not required to report to the SEC

− However your customers may have reporting obligations that you may have to support

Conflict Minerals


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• Starting in 2014- New Form SD must be filed with the SEC - By May 31 for the previous calendar year

• Form SD requires the issuer to- Conduct a “reasonable country of origin” inquiry- Determine the source of Conflict Minerals in its

products

• The issuer is required to disclose findings of the inquiry in the Form SD

• Based on the outcome of the inquiry- May be required to attach a Conflict Minerals

report- As an exhibit to the Form SD

Conflict Minerals - Compliance


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SEC Flowchart


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QAD’s Core Quality Mgt Solution


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• Core Quality Management• Traceability Solutions• Item Attributes • Enhanced Quality

QAD’s Core Quality Mgt Solution


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• Stores the definitions of standard testing procedures

• Applies tests to works orders & repetitive schedules

• Holds quality test results

• Manages inventory sampling plans & quality orders

• Tracks supplier product quality at incoming inspection, testing, during manufacturing, and inventory sampling

• Trend reports by supplier or part to help identify potential problem parts or suppliers

• Certificate of Analysis generated for parts indicating testing performed, detailed comments, pass/fail

Core Quality Management – SE & EE


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Traceability in QAD Enterprise Applications


Receiving Production Shipment

• Lot/Serial Control- Complete lot & serial no. tracking history- Foundation for cGMP compliance- Foundation for product liability tracking

• WIP lot tracking- Control combining and splitting of lot and

component material- Control the WIP inventory quantity-on-hand- Trace component material lots consumed- Trace WIP material lots from operation to

operation

Core SE & EE Functionality


• A Unique Identification Number

Serialization – Core EE


• Packaged Inventory using a unique ID

What is License Plate Inventory?

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• Single access point to current lot-controlled inventory and historical data

• Backward & forward tracing- Flexible and extended list of search criteria- Extended list of relevant information- Trace within a trace- Drill down capabilities- Data extraction- Saved search trails

Lot Trace Workbench – Core EE


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• Expands the breadth and depth of information for items, and optionally for item lots and sub-lots

• Maintain attributes by managing attribute profiles for items to support business operations

Item Attributes Solution – Core EE


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• Test specifications built using attributes• Test records and quality orders

- Test records for production operations- Quality orders with test records for inventory

lots- Update item lot and sublot attributes

Enhanced Quality Control – Core EE


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Bob Herdoiza

Cebos Quality Management System


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• 18+ Year Old Software Company

• Management System Standards Focus

• Division of QAD

• Division Headquarters in Brighton, MI

• Certified to ISO 9001:2008

CEBOS Overview

Integrating QAD and the Quality Management System

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• Comply with quality standards (ISO, TS, AS, FDA, etc.)

• Automate required business processes• Integrate related quality processes and QAD


Training Management

Audit Management

Gage Calibration

Dashboard Reporting

Supplier CAPA

Document Control

Corrective Action / Nonconformance

Project Management

APQP, PPAP, Risk Management

Quality Data Collection

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Current State


• Multiple databases (Office, Access, point solutions)

• Manual driven systems• Minimal linkage of data• Duplicate data entry• Minimal structure and consistency

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Current State


GMP ISO WEEE/RoHS

Doc’s

Training

CAPA

Audits

Supplier

Doc’s

Training

CAPA

Audits

Supplier

Doc’s

Training

CAPA

Audits

Supplier

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Future State – Integration


GMP ISO WEEE/RoHS

Doc’s

Training

CAPA

Audits

Supplier

Doc’s

Training

CAPA

Audits

Supplier

Doc’s

Training

CAPA

Audits

Supplier

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Integrating QAD and the Quality Management SystemFunctionality – Dashboards & Workflow

• Gadgets

• Drag and Drop

• Graphical

• Configurable

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Functionality – Document Control

• Central repository

• Formal change request process

• Automation of the change request process

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Functionality – Problem Solving

• Configurable

• Closed loop

• Automated reporting

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Functionality – Training Tracking

• Recurring

• Competency

• Document control

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E-Sync

E-Sync Functional Description• Compare data source with MQ1• Add/update records in MQ1• Employees, items, customers, etc.

XML File Transfer

System’s Integration

Tools

Integration Toolkit

XML Integration Functional Description• Standard XML web services• Push/Pull Data• Inspection/Inventory/CAPA• Training check• Gauge calibration check

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Conclusion


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• High Tech manufacturers face numerous safety and environmental regulations.

• Compliance requires a combination of internal controls, data collection and management, and reporting.

• QAD has the solutions to help you comply with current and future regulations whether you are running the Standard or Enterprise Edition.

Summary


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• Determine what regulations your company must meet

• Visit QAD.Com for more information on QAD’s quality management solutions

• Schedule a Vision Engagement• Let QAD help you determine an approach

for compliance through a QSCAN engagement

Next Steps


quality management for high technology hank canitz – sr. director industry solutions, qad bob...

Documents

qad core solutions

sole discretion of qad

cost of regulations

new electronic equipment

unique regulations

environmental performance

electronic mfgs

treatment recovery of